Back to resultsA Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQ-A3334
Placebo
Entecavir Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- 1. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA > 10^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;
Exclusion Criteria:
- 1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
Sites / Locations
- The second affiliated hospital of chongqing medical university
- The first hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TQ-A3334 combined with entecavir
Placebo combined with entecavir
Arm Description
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Outcomes
Primary Outcome Measures
Cmax
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Tmax
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
AUC0-t
To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.
Cytokine
Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.
Secondary Outcome Measures
HBV biomarker
Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg.
Lymphocyte function
Analysis of immune cell response to hepatitis B antigen after treatment.
Full Information
NCT ID
NCT04180150
First Posted
November 26, 2019
Last Updated
December 12, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04180150
Brief Title
A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
Official Title
A Randomized, Double-blinded, Placebo-controlled, Phase IIa Study of TQ-A3334 Combined With Entecavir in the Treatment of Untreated or HBV DNA Negative Subjects With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQ-A3334 combined with entecavir
Arm Type
Experimental
Arm Description
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Arm Title
Placebo combined with entecavir
Arm Type
Placebo Comparator
Arm Description
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Intervention Type
Drug
Intervention Name(s)
TQ-A3334
Intervention Description
TQ-A3334 is a kind of TLR7 receptor agonist.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is a treatment which is designed to have no therapeutic value.
Intervention Type
Drug
Intervention Name(s)
Entecavir Tablet
Intervention Description
Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.
Primary Outcome Measure Information:
Title
Cmax
Description
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Time Frame
Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Title
Tmax
Description
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
Time Frame
Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Title
AUC0-t
Description
To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.
Time Frame
Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Title
Cytokine
Description
Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.
Time Frame
Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.
Secondary Outcome Measure Information:
Title
HBV biomarker
Description
Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg.
Time Frame
Day 1 pre-dose, day 84, day 168, day 336 post-dose.
Title
Lymphocyte function
Description
Analysis of immune cell response to hepatitis B antigen after treatment.
Time Frame
Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA > 10^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;
Exclusion Criteria:
1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junqi Niu, M.D.
Phone
0431-88782168
Email
junqiniu@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Ren, M.D.
Phone
023-63693213
Email
renhong0531@vip.sina.com
Facility Information:
Facility Name
The second affiliated hospital of chongqing medical university
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Ren, M.D.
Phone
023-63693213
Email
renhong0531@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Hong Ren
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jinlin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, M.D.
Phone
0431-88782168
Email
junqiniu@aliyun.com
First Name & Middle Initial & Last Name & Degree
Junqi Niu
12. IPD Sharing Statement
Learn more about this trial
A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
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